Decubitus ulcers, also known as pressure sores, are difficult to treat medical problems that can lead to serious consequences. Pressure sores occur when the skin breaks down as a result of continuous pressure, thus forming open sores. Pressure sores frequently affect the skin over bony prominences of the body. Areas most commonly affected include the skin over the heel, ankle bones, coccyx or tailbone, trochanters or hip bones and the sacral area of the lower back.
An estimated 2 to 3 million people in the United States are affected by pressure sores, with most of them being elderly. One study showed that over 12% of nursing home residents developed pressure sores within their first year. This number increases to 20% after 2 years. Moreover, an estimated 60,000 people die from pressure sore complications every year.
Pressure sores occur when there is a lack of blood supply to a dependent area of the body. This lack of blood supply is caused by compression of the skin and underlying soft tissue between the bony prominence and a supporting surface, such as a mattress. The weight of the body part exerts sufficient pressure to impair the blood supply to the soft tissue and skin. If this impairment of the blood supply is prolonged, permanent injury results causing necrosis or death of the skin and underlying soft tissue in the affected area. Other factors causing pressure sores include friction of the skin against bed sheets, casts or braces.
Pressure sores commonly affect individuals with limited mobility, such as those confined to a bed because of illness, injury or old age. These are frequent problems in nursing home patients, especially those with circulatory problems, or impaired sensations because of diabetes or stroke.
Once a pressure sore occurs, treatment is very difficult and time consuming, often requiring weeks or months of wound care. Dressing changes are usually painful to the patient. Complications, including localized or generalized infection, may be serious and commonly require hospitalization for proper treatment. Surgical intervention is frequently required, including debridement or excision of dead tissue, skin grafting and even leg amputation.
Pressure sores are generally considered to be a preventable condition, but prevention has proven to be difficult, time consuming and costly. Prevention requires avoiding prolonged pressure on any area of the skin by frequently moving the patient, and attention to skin care is required to avoid irritation or chaffing.
Published patent application no. 2003/0032485 to Flam et al. discloses a number of skin protective devices for preventing pressure sores. In particular, the skin protective devices have an inner surface which conforms to the body part to be protected, and is made of a material suitable for distributing the weight of the body part over an extended area.
A bed pad comprising a plurality of air-filled cells for treating pressure sores is disclosed in U.S. Pat. No. 5,462,519 to Carver. A skin protective device for ankles, heels and elbows is disclosed in U.S. Pat. No. 5,944,683 to Baranowski. In Baranowski, the skin protective device is a cushion formed of a closed cell foam having a resilience with respect to pressure. The resilient cushioning foam may include air, gel or water.
Other skin protective devices such as air mattresses and floatation beds, foam, silicon gel, sponge rubber and sheepskin pads of various shapes have been available—but these are difficult to apply or maintain in position. Moreover, some are uncomfortable to the patient and some are prohibitively expensive.
In spite of these efforts, the incidence of pressure sores has not diminished. In fact, the problem is becoming more frequent as the population ages. More individuals require long-term care and are confined to nursing homes. As nursing homes become more short-staffed, caregivers have even less time to devote to frequently changing a patient's position, and to providing attention to skin care. There exists a need for a straightforward skin protective device that can be easily applied to a vulnerable area of the body, stays in position once applied, and does not cause discomfort.